FDA WARNING_LETTER - Sandeep Bagla, MD - July 31, 2013

This Warning Letter from the FDA to Dr. Sandeep Bagla details objectionable conditions observed during an inspection from July 8-31, 2013, concerning the "Prospective Pilot Study of Prostatic Artery Embolization in the Treatment of Benign Prostatic Hyperplasia" using Celonova Embozene Microspheres. The device was used for an unapproved indication (BPH, not hypervascular tumors or arteriovenous malformations), constituting a significant risk (SR) device study.

Key violations include: 1. **Failure to submit and obtain FDA approval for an IDE application** for an SR device study (21 CFR 812.20(a)(1), 812.42, 812.110(a)). The study began without FDA approval. Corrective actions, including study suspension, were noted but deemed inadequate without documentation of subject notification. 2. **Failure to conduct the investigation according to the investigational plan** (21 CFR 812.110(b)). Seven subjects did not receive required 2-week post-PAE physical examinations, increasing risks. The response regarding protocol amendment for telephone interviews was inadequate as the submitted protocol did not reflect this change. 3. **Failure to include a description of procedures in the informed consent document (ICD)** (21 CFR 50.25(a)(